Cleared Special

Precision AI Surgical Planning System (PAI-SPS)

K243955 · Precision AI Pty, Ltd. · Orthopedic

Jan 2025

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K243955 is an FDA 510(k) clearance for the Precision AI Surgical Planning System (PAI-SPS), a Shoulder Arthroplasty Implantation System (Class II — Special Controls, product code QHE), submitted by Precision AI Pty, Ltd. (Fortitude Valley, AU). The FDA issued a Cleared decision on January 21, 2025, 29 days after receiving the submission on December 23, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3660.

Submission Details

510(k) Number	K243955 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 23, 2024
Decision Date	January 21, 2025
Days to Decision	29 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	QHE — Shoulder Arthroplasty Implantation System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3660
Definition	Intended To Be Used To Assist In The Implantation Of A Specific Shoulder Arthroplasty Device Or A Set Of Specific Shoulder Arthroplasty Devices. Indicated To Include Guiding Alignment, Making Or Establishing Cuts, Selecting, Sizing, Attaching, Positioning Or Orienting Implant Components.